The purpose of this research is to study a medication called liposomal bupivacaine (EXPAREL®). Study doctors want to see if it is safe, if it can reduce pain after surgery, and the study doctor want to study its use after the removal a soft tissue tumor called a sarcoma
The hypothesis for this project is that using liposomal bupivacaine will reduce patients' morphine equivalent usage postoperatively while maintaining similar pain scores and lengths of stay when compared to patients that did not receive intraoperative liposomal bupivacaine. Thus, if the use of liposomal bupivacaine proves to aid in pain control and the reduction of initial opiate use following soft tissue sarcoma resection, it could be reasonably suggested that liposomal bupivacaine become incorporated into a multimodal form of pain management following soft tissue sarcoma resection. These results are expected to have a significant positive impact; allowing for a reduction in narcotic pain medication usage and its associated side effects while decreasing health care expenditures.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
A 25 gauge or larger bore needle will be used to inject the liposomal bupivacaine at the site of operation following the prescription guidelines provided by Exparel®. The maximum dose allowable for this study is 266mg or 20 mL as indicated in the FDA package insert.
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Number of participants with peak pain scores measured by VAS less than 7
Feasibility of Exparel for post surgical pain management in soft-tissue sarcoma surgeries of the thigh will be defined as peak pain score measured by VAS (Visual Analogue Scale) less than 7. VAS scores range 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.
Time frame: Up to 24 hours
Peak Pain Scores during hospital stay post surgery
Peak pain scores will be measured by VAS (Visual Analogue Scale) which is printed on the Post-Operative Pain and Medication Administration questionnaire. VAS ranges 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.
Time frame: Up to 5 days
Amount of opiate use post-operatively while the patient is in the hospital in milligram morphine equivalent (MME)
The opioid medications that the subject uses will be recorded and the data regarding total narcotic usage will be converted to MME to maintain a standard unit for the study.
Time frame: Up to 5 days
Number of surgical-related infection
Number of surgical-related infection will be documented by use of Treatment Follow-Up Form and Adverse Event Log.
Time frame: 6 week post surgery
Average Pain Scores during hospitalization
Average pain scores will be measured by VAS (Visual Analogue Scale). VAS ranges 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.
Time frame: up to 5 days
Length of time in hospital
The unit of time used to record length of stay will be days. Defined as the time from entry into the post anesthesia care unit (PACU) to discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: End of hospitalization (up to 30 days)
Rate of approached and consented patients
The rate will be calculated with the number of participants that consented divided by the number of patients approached about the study
Time frame: end of the study up to 2 years